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Procedure
Tenex Procedure for Frozen Shoulder (CHLTenex Trial)
N/A
Waitlist Available
Led By Sayed Wahezi, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have tried other conventional therapies like steroid treatments, surgical treatments, physiotherapy with little (defined by less than 20 degrees improvement in shoulder ROM - external rotation) to no improvement in the shoulder ROM
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before the procedure) the procedure and at 1 month
Awards & highlights
CHLTenex Trial Summary
This trial is testing a new way to treat frozen shoulder that involves cutting the coracohumeral ligament.
Who is the study for?
This trial is for adults with Frozen Shoulder, who have a thickened ligament seen on ultrasound and very limited shoulder movement despite trying steroids, surgery, or physiotherapy. It's not for those under 18 or over 89 years old, pregnant individuals, or patients improving with physical therapy.Check my eligibility
What is being tested?
The study tests a procedure called Percutaneous Interruption of the Coracohumeral Ligament using Tenex technology alongside a local anesthetic to treat Frozen Shoulder in people who haven't responded well to other treatments.See study design
What are the potential side effects?
Possible side effects may include discomfort at the treatment site, bruising, swelling, infection risk from the skin puncture and temporary increase in shoulder pain following the procedure.
CHLTenex Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have already tried other treatments like medications, surgery, and physical therapy, but they didn't improve your shoulder movement by at least 20 degrees in external rotation.
CHLTenex Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (before the procedure) and at 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before the procedure) and at 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Range of Motion of the shoulder
Secondary outcome measures
Change in Range Of Motion (ROM) of the shoulder
Change of pain intensity score
Opioid prescription use
CHLTenex Trial Design
2Treatment groups
Experimental Treatment
Group I: Tenex plus local anestheticExperimental Treatment2 Interventions
Use of the TENEX device for sectioning of the CHL
Group II: Local AnestheticExperimental Treatment1 Intervention
Only Local anesthetic will be injected into the CHL. This arm will have the option to cross over into Tenex arm at 1 month
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Local anesthetic
2019
Completed Phase 1
~380
Find a Location
Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,854,593 Total Patients Enrolled
Sayed Wahezi, MDPrincipal Investigator - Montefiore Medical Center
Albert Einstein College of Medicine
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have a condition called adhesive capsulitis in your shoulder, but you are steadily improving your shoulder movement with physiotherapy.You have already tried other treatments like medications, surgery, and physical therapy, but they didn't improve your shoulder movement by at least 20 degrees in external rotation.You are currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Tenex plus local anesthetic
- Group 2: Local Anesthetic
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical experiment open to individuals aged 35 and above?
"This trial dictates that participants must be between 18 and 89 years old, inclusive."
Answered by AI
What criteria should prospective participants satisfy to be eligible for enrollment?
"To qualify for the study, individuals should have bursitis and be within 18 to 89 years of age. This research is looking for approximately 49 candidates."
Answered by AI
Is enrollment for this research still available?
"This study, which was first announced on November 17th 2020, is no longer recruiting participants. However, current data hosted by clinicaltrials.gov reveals that there are 37 other trials actively seeking individuals to take part in their research."
Answered by AI
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